Regulatory Affairs Associate Director

About Amgen

Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.

Role description :

Amgen is seeking a Regulatory Affairs Associate Director supporting lifecycle management for approved, mature products across all Amgen Therapeutic Areas. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules. In this important, product-facing role you will lead assigned Global Regulatory Teams (GRT) in the Regulatory Affairs organization.

The role of the Regulatory Affairs Associate Director is to lead GRTs within Amgen's GRAAS organization, develop a comprehensive regulatory strategy that takes into account worldwide regulatory requirements, maintain compliance with global registrations, maintain labeling, oversee effective regulatory agency interactions, and provide regulatory expertise and guidance to product teams.

Key Responsibilities :

• Develop and execute the global regulatory product strategy
• Lead GRTs
• Represent Regulatory on the product team and other key cross-functional teams and commercialization governance bodies
• Obtain input from the GRT members to develop a global regulatory strategy which supports lifecycle maintenance.
• Identify and communicate regulatory risks
• Develop strategies and plans to maintain regulatory approvals and product labeling
• Provide regulatory direction in the development of the core data sheet in the context of available and expected scientific data, regulatory guidance and precedent
• Lead the planning and implementation of global regulatory filings (e.g. label extensions, CMC changes)
• Ensure consistency of evidence-based global product communication (e.g. regulatory submission documents)
• Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment
• Ensure guidance on regulatory mechanisms to optimize lifecycle management is assessed and incorporated into the global regulatory strategy
• Communicate consistently well defined, successful regulatory strategies throughout the organization such that expectation is understood
• Ensure effective regulatory agency communications by leading core regulatory and cross functional teams (e.g. GRTs, filing teams)
• Attend key regulatory agency meetings which could impact the global product strategy
• Represent Amgen Regulatory on external partnership teams at the product level

Basic Qualifications and Experience :

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Doctorate degree and 3 years of regulatory experience in biotech or science Or

Master's degree and 6 years of regulatory experience in biotech or science Or

Bachelor's degree and 8 years of regulatory experience in biotech or science

Soft Skills :

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

Skills Required

Regulatory Affairs, lifecycle management , regulatory filings